Description of Event or Problem · 0
THE COMPLAINANT IS A 53 Y/O WOMAN, WHO WAS MEDICALLY PREDIAGNOSED WITH SPINAL CORD CONDITION IN (B)(6) 2019. ON (B)(6) 2021, DR. (B)(6) AND DR. (B)(6), PROVIDED HER WITH THIS DEVICE AND INITIALLY, IT WORKED AND ASSISTED HER WITH PAIN. ON (B)(6) 2022, THE DOCTORS SHIFTED THE DEVICE, BECAUSE SHE BEGAN EXPERIENCING INCREASING PAIN IN THE SPINAL AND BUTTOCKS AREA. THE DOCTORS TOLD HER THAT THEY WERE SHIFTING THE DEVICE DUE TO SCAR TISSUE IN THE AREA WHERE THE DEVICE WAS PLACED DUE TO PRIOR SURGERIES TO IMPROVE IT'S EFFECTIVENESS. THREE WEEKS AGO, SHE WAS TRYING TO GET A SPECIAL MRI AND WAS DENIED. SHE CONTACTED ABBOTT AND A REP FROM ABBOTT MET HER AT (B)(6) TO FIX THE REMOTE, WHICH HAD DEFAULTED AND THE DEVICE WAS NOT WORKING. FOLLOWING THIS, SHE FELT TINGLING DOWN HER LEGS, BUT DIDN'T FEEL STIMULATION IN HER SPINE AND BUTTOCKS AREA AS SHE SHOULD HAVE AND WAS TOLD BY THE ABBOTT REP THAT, "SHE WAS WAY GONE" REGARDING HER SPINE AND BUTTOCKS AREA. (B)(6) REMOVED THE DEVICE ON (B)(6) 2023 FOLLOWING ABBOTT NOTIFICATION THAT THIS PRODUCT HAD BEEN RECALLED. THE COMPLAINANT STATED THAT SHE ONLY RECEIVED THIS NOTIFICATION LAST WEEK AND WAS CONCERNED THAT IT ONLY HAD JUST BEEN RECEIVED. SHE WAS TREATED WITH MUSCLE RELAXERS AND HAS BEEN SELFMEDICATING WITH TYLENOL. THE COMPLAINANT GAVE PERMISSION TO SHARE HER NAME AND CONTACT INFORMATION WITH THE COMPANY. SHE HAD NOTIFIED ABBOTT OF PER RECALL ANNOUNCEMENT, RES #92688, CLASS 1 RECALL DATE INITIATED BY ABBOTT, 07/18/2023, DATE POSTED 09/11/23, RECALL #Z-2505-2023, ABBOTT IS RECALLING ITS PROCLAIM AND INFINITY IPGS DUE TO COMPLAINTS FROM PATIENTS WHO ARE UNABLE TO EXIT MRI MODE. THE PATIENT CONTROLLER (IPHONE/IPOD) MAY LOSE THE ABILITY TO CONNECT OR COMMUNICATE WITH ITS IPG WHILE IN MRI MODE" RES #92688. (B)(6), ABBOTT MEDICAL RESPONSES CONTINUED FROM PG. 2 ("INIT DISP REMARKS"); "HAS YOUR FIRM RECEIVED ANY SIMILAR COMPLAINTS? RESPONSE: THE PATIENT REPORTED RECEIVING UNWANTED STIMULATION IN HER LEGS AND WAS NOT RECEIVING STIMULATION IN HER BACK AND BUTTOCKS AS DESIRED. "YOUR RESPONSE TO THIS COMPLAINT. RESPONSE: A REVIEW OF THE AVAILABLE INFORMATION DETERMINED THE PATIENT'S COMPLAINT OF IPG MIGRATION CAUSING PAIN AND INEFFECTIVE THERAPY, RESULTING IN THE SCS SYSTEM BEING EXPLANTED, IS REPORTABLE. PLEASE SEE (B)(4) (MFR.'S 3006705815-2023-06998, 3006705815-2023-06999 AND 3006705815-2023- 07000), SUBMITTED ON 30 OCT 2023. THE PATIENT'S IPG WAS INCLUDED IN THE NEUROMODULATION IMPLANTABLE PULSE GENERATOR (IPG) UNABLE TO EXIT MRI MODE ADVISORY NOTICE ISSUED BY ABBOTT ON 22 JUNE 2023. HOWEVER, BASED ON THE REPORTS TO ABBOTT THERE IS NO INDICATION THAT THE PATIENT HAS UNDERGONE AN MRI, OR THAT THE DEVICE WAS UNABLE TO EXIT MRI MODE. AS SUCH, THE EVENTS DO NOT APPEAR TO BE CONNECTED TO THE RECALL ISSUE."